Wednesday, 20 October 2010

FDA to Rescind Menaflex Approval

The Food and Drug Administration has admitted that serious errors were made during the approval for the knee device Menaflex, manufactured by New Jersey-based ReGen Biologics. According to the agency, the review process for the approval of the device was insufficient. The agency has confirmed that it will soon begin the process of rescinding approval of the device, which was approved two years ago.

It's not every day that California pharmaceutical liability lawyers find the FDA making the decision to rescind approval of a device. However, the Menaflex situation has presented many challenges to the FDA. It has been the subject of criticism targeted at the FDA, especially its fast-track process or 510(k). A majority of the medical devices approved by the FDA are approved though this fast-track process, which is meant to be used to approve those devices that are reasonably similar to other devices already approved and available on the market. However, the process and its misuse/abuse has come under the microscope in recent years.

The Menaflex knee device, which is meant to repair damaged knee tissue, was approved under the 510(k). According to the FDA, starting from December 2007, agency officials who were reviewing ReGen Biologics’ application for Menaflex approval began receiving calls from members of Congress about the review process. The pressure began to mount on the agency to get the device approved. During the review process, four New Jersey lawmakers including two representatives and two senators, appealed to the agency on behalf of ReGen Biologics. Lawmakers now say they did nothing wrong in appealing to federal agencies to clear bureaucratic hurdles faced by the New Jersey company.

The pressure worked, and Menaflex was approved in spite of the objections of several scientists at the FDA, who insisted that there was little or no benefit from using the device.

That approval is likely to be rescinded soon, and ReGen Biologics has already made clear its displeasure at the decision.